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Combifix™ Baseplate
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 151014MRModel Breast and Pelvis
by Medtec LLC
Identity
- Trade Name
- Combifix™ Baseplate FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- Combifix™ Baseplate FDA UDI
- Model / Reference
- 151014MR EUDAMEDFDA UDIBreast and Pelvis EUDAMED
- Description
- Combifix™ Baseplate FDA UDI
Identifiers
- Catalog Number
- 151014MR FDA UDI
- Primary DI / UDI-DI
- 00841439111871 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Radiological arm/leg positioner
Combifix™ Baseplate by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI b2edca5e-818c-4099-85c9-7820f1100ece 36 fields · synced Jul 12, 2026
- EUDAMED a970883b-51fb-4de3-979e-11f547112a0f 61 fields · synced Jul 12, 2026